The FDA is collaborating with industry to enable a highly connected device ecosystem to strengthen product quality, innovation, and safety. On the table? The notion of compliance and quality. Are they the same?
From the FDA’s standpoint, compliance is critically important. It is the foundation and the starting point within the medical device industry and the life sciences sector in general. However, they believe the needle needs to move toward quality ― where patients and patient outcomes become the number one priority.
The evolution from compliance to a proactive learning system focused on patient quality outcomes involves overcoming several barriers, many of which are tied to the limited adoption of advanced technology and digital tools. The FDA’s Case for Quality (CfQ) initiatives that have been specifically designed to overcome these barriers include: the CfQ Voluntary Improvement Program (VIP), CfQ Collaborative Community, Medical Device Information & Analysis Sharing (MDIAS) Platform & Partnership, and advanced manufacturing technology clearinghouse.
Of course, moving to this future state would require collaboration between the agency and industry, with the industry expected to focus on building excellence into every stage of the product lifecycle.
“The idea for delivering high-quality products is very simple ― design excellence, manufacturing excellence, supply excellence, and servicing excellence. If we’re improving any of these areas, everything moves in a positive direction,” Vicenty said. He underscored that the end goal isn’t the regulation.
Vicenty outlines key steps in the journey toward this future state:
- Patients and patient outcomes must become the industry’s number one priority
- Data and digital integration adoption by all stakeholders
- The industry must lead the way with best practices
- The industry and FDA must make learning a collaborative experience
About Francisco Vicenty
Francisco (Cisco) Vicenty is Program Manager for the Case for Quality (CfQ), Office of Compliance. This effort is part of the CDRH Surveillance and Biometrics strategic priorities. This strategic priority will improve access and outcomes for patients by engaging industry, payers, providers, and patients to increase focus on the quality and performance of medical devices. Cisco began his career at FDA as a Compliance Officer, Cardiac Rhythm/Electrophysiology Branch, Office of Compliance at CDRH. He then worked as a project manager, FDA’s Case for Quality initiative. Prior to his current role, Cisco was Branch Chief, Respiratory, E/N/T, General Hospital, & Ophthalmic Devices Branch in the Div. of Mfg. and Quality, Office of Compliance. Prior to working with FDA, Cisco Vicenty was a Quality and Reliability Engineer with Micro-Electronics Business Unit at IBM responsible for emerging server technology lines and network systems along with high volume gaming systems from Nintendo, Sony, and Microsoft.